R3, STIKTITE 71338664Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556020630), received between Jul 3, 2018 and Nov 13, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K092386, K211176); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED A DISLOCATION. AN ANTEVERSION OF THE R3 CUP WAS NOTED TO BE A LITTLE INSUFFICIENT. A REVISION SURGERY WAS PERFOMRED ON (B)(6) 2023, IN WHICH THE CUP, LINER AND SCREW WERE EXCHANGED TO COMPETITOR PRODUCTS (ZIMMER). ALSO, THE FEMORAL HEAD WAS EXCHANGED TO OXINIUM HEAD, JUST THE STEM WAS NOT EXPLANTED. HOWEVER, THE SURGEON DID NOT THINK IT WAS A FAILURE OF THE DEVICES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 18120750 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2015, THE PATIENT EXPERIENCED INFECTION AND DISLOCATION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 12492121 ↗
• InjuryMar 13, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO LOOSENING. THE R3 MULTI-HOLE ACETABULAR SHELL 50MM WAS EXPLANTED. THE PATIENT IS ALSO COMPLAINING ABOUT PAIN AND FEELING STRANGE.

  Patient problems: Injury

  MAUDE report 9828575 ↗
• InjuryAug 22, 2018Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION.

  Patient problems: No Information

  MAUDE report 7805865 ↗
• InjuryJul 3, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. THE SURGEON DEEMED THAT THE CAUSE OF THIS FAILURE WAS CUP MALALIGNMENT. THE SURGEON DOES NOT FAULT THE DEVICE. THE PRODUCT IS NOT AVAILABLE. NO MORE INFORMATION AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 7657629 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092386, K211176. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.